An Exploratory Study of ZB-06 as a Vaginal Contraceptive Film

NCT ID: NCT04731818

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-08
• Study Completion Date: 2022-02-24

Brief Summary

This is an early Phase 1 study to establish proof-of-concept by determining whether an intravaginal film containing a human contraceptive antibody (ZB-06) shows promise to provide contraceptive efficacy using the post-coital test, a surrogate measure of efficacy. The study will also evaluate the safety and pharmacokinetics of ZB-06.

Conditions

Contraception

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ZB-06

All participants will receive a single ZB-06 film for intravaginal administration prior to intercourse.

Group Type: EXPERIMENTAL

ZB-06

Intervention Type: BIOLOGICAL

ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.

Interventions

ZB-06

ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Age 18 - 50 years, inclusive
• General good health, by volunteer history and per investigator judgment
• History of regular menstrual cycles of 21 - 35 days (inclusive), by volunteer report
• History of a normal PAP smear or ASCUS with negative HPV testing within the previous 12 months
• Willing to abstain from intercourse and use of vaginal medications, lubricants, and other products as required in the protocol
• Willing to use non-spermicidal, lubricated condoms for any vaginal intercourse from the first day of each menstrual cycle until 72 hours before expected midcycle
• In a mutually monogamous relationship with a male partner who:

• Is at least 18 years old
• Has no known risk for sexually transmitted infections (STIs)
• Is willing and able to comply with protocol requirements including sexual activity/ abstinence and condom use requirements
• Can engage in vaginal intercourse with the participant, with and without condoms, as specified in protocol
• Protected from pregnancy by female surgical sterilization
• Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy genital tract sample collection
• Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol

Exclusion Criteria

• History of hysterectomy
• Surgical sterility or known history of infertility in male partner
• Sterility or known history of sperm dysfunction in male partner
• Currently pregnant by urine pregnancy test at the enrollment visit, or within two calendar months from the last pregnancy outcome. Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome
• Current use of any hormonal contraceptive or a copper or hormonal IUD, or use of Depo-Provera in the last 120 days
• Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study
• Significant gynecological abnormalities (including abnormal vaginal bleeding, excessive vaginal discharge, or vulvar/vaginal pain or irritation)
• Current UTI, vaginal candidiasis, or symptomatic bacterial vaginosis
• History of sensitivity/allergy to ZB-06 film components, for either the volunteer or her male partner
• In the last three months, either the volunteer or her male partner diagnosed with or treated for any STI or pelvic inflammatory disease, or either partner with known risk factors for sexually transmitted infections. Note: Women with a history of genital herpes or condylomata who have been asymptomatic for at least six months may be considered for eligibility
• Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, or HIV at the screening visit
• Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for an STI
• Known current drug or alcohol abuse which could impact study compliance
• Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study
• History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days
• Abnormal finding on laboratory or physical examination or a social or medical condition in either the volunteer or her male partner which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eastern Virginia Medical School

OTHER

Sponsor Role: collaborator

KBio Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eastern Virginia Medical School

Norfolk, Virginia, United States

Countries

United States

References

Thurman AR, Moench TR, Hoke M, Politch JA, Cabral H, Mausser E, Nador E, Morton J, Hamorsky K, Swope K, Bratcher B, Anderson DJ, Whaley KJ. ZB-06, a vaginal film containing an engineered human contraceptive antibody (HC4-N), demonstrates safety and efficacy in a phase 1 postcoital test and safety study. Am J Obstet Gynecol. 2023 Jun;228(6):716.e1-716.e12. doi: 10.1016/j.ajog.2023.02.024. Epub 2023 Mar 2.

Reference Type: DERIVED

PMID: 36870409 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ZB-06-01

Identifier Type: -

Identifier Source: org_study_id